The following data is part of a premarket notification filed by Continental X-ray Corp. with the FDA for Classic-ii 4-way Horizontal Table Cat.# T-9111.
| Device ID | K912516 |
| 510k Number | K912516 |
| Device Name: | CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 |
| Classification | Table, Radiographic, Non-tilting, Powered |
| Applicant | CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Contact | Oscar Khutoryansky |
| Correspondent | Oscar Khutoryansky CONTINENTAL X-RAY CORP. 2000 SOUTH 25TH AVE. Broadview, IL 60153 |
| Product Code | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-06 |
| Decision Date | 1991-11-19 |